The effectiveness of two different valgus braces in the treatment of varus medial compartment osteoarthitis of the knee: a randomized clinical trial
Completed
- Conditions
- arthrosis of the kneegonarthrosis10023213
- Registration Number
- NL-OMON34102
- Lead Sponsor
- Alysis Zorggroep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Patients with medial knee osteoarthritis (confirmed on X-ray (AP and lateral) using the Kellgren classification).
Medial knee pain.
Varus leg alignment (confirmed on X-ray).
Age between 18-70.
Exclusion Criteria
Insufficient command of the Dutch language.
The inability to apply brace because of physical or cognitive limitations.
Symptomatic back/hip/ankle/foot pathology (which makes improvement of pain, function, quality of life and satisfaction, by wearing a brace, impossible).
Other than osteoarthritis causing knee pain (like arthritis).
Pre-existing skin problems.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in the VAS pain score at 3 months between the Bledsoe Thruster group<br /><br>and the SofTec OA Brace group. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Visual Analogue Scale for pijn and satisfactio (VAS-pain, VAS-satisfaction),<br /><br>the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the<br /><br>SF-12 and the 6-Minutes Walking Test at baseline, 2 weeks and 3 months.<br /><br>Radiographs of varus leg alignment at baseline without brace and at 3 months<br /><br>with brace.<br /><br>Patients need to keep a diary once a week during the 3 months of participation.<br /><br>In this diary they record mean daily analgesics use, complications and<br /><br>compliance. </p><br>